This is a multi-center, open-label, phase IIa study to evaluate the pharmacokinetics (PK),
safety, and efficacy of APG-115 as a single agent or in combination with APG-2575 in patients
with T-PLL. The study consists of two parts. A total of 24-36 T-PLL patients will be
In Part 1, 12-18 participants will be enrolled using a 3+3 dose escalation design. Patients
receive APG-115 orally once every day (QD) with meal on Days 1 to 5, and 23 days off in the
In Part 2, patients receive APG-115 orally QD on Days 1 to 5, followed by 23 days off in a
28-day cycle. APG-115 dose escalation will use a standard 3+3 design starting from 150 mg,
followed by 200 mg, then 250 mg. APG-2575 will be administered at 800 mg after ramp-up
period. To prevent tumor lysis syndrome (TLS), APG-2575 needs to follow a 3-day daily ramp-up
schedule from 200 mg before the fixed dose 800 mg is reached.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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